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13 of August, 2015 In: CFR, FDA, FSA, guides, QA, QC, Quality Assurance, USDA 0

Binder? What binder? There's a BINDER?

written by:Marko Gospojevic

Do you remember your first day on the job in QA (Quality Assurance) or QC (Quality Control)?

I sure do. I started directly out of college as a QC laboratory chemist and worked my way up, but there are two things I remember well from that first day: First, my laboratory trainer kept introducing me as a “whippersnapper,” which I thought was a fish until I Googled it…talk about embarrassing. I also remember a huge, white, three-ring binder. It was well used, the cover was worn, and the pages were crinkled and faded. But what it contained! All of the QC and QA acronyms, industry guides, a compilation of experiences (even the bad ones), QC definitions, standard operating procedures, scientific references, laboratory methods…so much information! Some might call it a cheat sheet, but we called it the Holy Grail of QC. As I progressed in my career, I developed my own binder with similar information for my employees, and I strongly suggest you do the same.

Let’s take a look at a few examples of what you might want to include in yours:

FDA Inspections

When I was first promoted to QA Coordinator I was young and cocky. So maybe I fit the whippersnapper definition after all. Despite whippersnapper status, my first week on the job, my boss decided to take a prolonged vacation. This meant that I was the only person on site trained in handling regulatory visits. Sure enough, who shows up at the door? The FDA, that’s who.

“Dude, no way this is happening,” I said to myself as I went to meet the FDA inspector in the waiting room, but then I remembered the tips from the QC binder. Because of that binder, I was able to properly ask the FDA inspector what was the purpose of his visit, recognize the type of form I was given (FDA Form 482, which informs you of the purpose of the visit, is quite common and nothing to worry about), and most important, realize what form I WASN’T given (no FDA Form 483, which would have meant to my 22 year old self: “Dude, I’m screwed.”).

There were a few things that weren’t in the binder that I had to learn the hard way—but you can bet I put them in my own binder.

Let’s fast forward about five years:

USDA FSA (Food Safety Assessment)

I’d been rapidly promoted to a Regional QA/QC Manager for the West Coast and, mind you, I was still considered a young punk, but at least I’d been through enough QA battles that I’d earned my stripes. But when a gentleman from the USDA showed up unannounced stating that he was an EIAO, I remember thinking to myself, “What the hell is that?” His card and badge quickly answered my question. Enforcement Investigations and Analysis Officer. An Enforcement Officer?!

“Dude come on, seriously?” (Of course I didn’t say that out loud—I’d passed Major Whippersnapper status by then.)

I honestly thought I was being shut down. My racing mind was quickly put to rest by the EIAO as he explained that they’re a group of specialized USDA officers in charge of FSA’s (Food Safety Assessments). These audits can last from a few weeks to a mind-boggling four months and are typically given every four years to each USDA establishment as part of a routine checkup. The frequency can be intensified if the facility has gone through a recent food recall or withdrawal. One of the best tools on how to prepare for any FSA and what to expect from an EIAO came to me from this very FSA. The USDA FSA tools website explains all aspects of the audit and how to prepare for it, and you can bet all of that info went into my cheat sheet binder.

CFR’s (Codes of Federal Regulations)

 The US government has a lot of CFR’s. And I do mean a lot. Fifty shades of titles to be exact. Each of these titles focus on a particular segment of Federal regulations. Since the laws change quickly, I soon learned that purchasing CFR books was useless, as the cost would quickly rack up. Instead, these two websites hold the most up-to-date CFR’s that you need to know regarding conventional products for both the FDA (21 CFR Website) and the USDA (9 CFR Website).

 You. Are. Welcome. 

Bonus Aside: State of California Health Codes

If you are one of the fortunate few who live and work in California, you need to be familiarized with its laws. I learned the hard way that the California health laws are much stricter. If you are moving to California to pursue a career in QA, the California Health and Safety Code Website will list every safety code you need to know. You may have heard of this being referred to as the Sherman Food, Drug and Cosmetics Law.

One idea to consider instead of using a physical binder would be to create an online folder, cloud file, or a simple USB drive. Please note that having any type of a binder for reference is not a requirement by any federal body, but as QA professionals it is our nature to share best practices with the world…or at least our colleagues.

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